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Antistreptolysin O
EUDAMEDClass IVD General (EU MDR)
Ref ASLTX-L00/CGR
by Diagam S.A.
Identity
- Trade Name
- Antistreptolysin O EUDAMED
- Device Name
- Antistreptolysin O EUDAMED
- Model / Reference
- ASLTX-L00/CGR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168010467 EUDAMED
- Basic UDI-DI
- B-05415168010467 EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Antistreptolysin O by Diagam S.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05415168010467 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (1)
- EUDAMED 48f9643b-d521-42a6-b835-fa9e86c92e77 61 fields · synced Jul 17, 2026